Safety, Efficacy, and Microbiological Summary

Transcription

1 HIGH-LEVEL DISINFECTANT AND STERILANT RAPICIDE PA Ready-to-Use Safety, Efficacy, and Microbiological Summary For use with Rapicide PA RTU outside of the USA, Canada and Australia Endoscope reprocessing the way it should be 1

2 Rev B 2011, MEDIVATORS, A Minntech Corporation Business Group All rights reserved. This publication is protected by copyright. Copying, disclosure to others or the use of this publication is prohibited without the express written consent of Minntech Corporation. Minntech reserves the right to make changes in the specifications shown herein without notice or obligation. Contact your Medivators representative or Medivators customer service for more information. 2

3 Contents Product Description... 4 Intended Use... 4 Safety... 5 Storage... 5 Neutralization and Disposal... 5 Efficacy... 6 Material and Endoscope Compatibility... 7 Biocompatibility... 9 Packaging Configuration

4 PRODUCT DESCRIPTION Rapicide PA RTU Ready-to-use (RTU) is a reusable solution for High-Level Disinfection (HLD) and sterilization of endoscopes and related accessories in compatible automatic endoscope reprocessing systems (AERs) and for the manual disinfection of compatible medical devices. It consists of two parts, Part A and Part B, which are mixed manually by the user prior to use. The Part A solution contains the active microbicidal ingredient while the Part B solution contains buffers, surfactants and corrosion inhibitors. The characteristics of the use-solution are: Active Ingredient: Peracetic Acid (PAA) Initial PAA Concentration Range: ppm Minimum Recommended Concentration (MRC): 1000 ppm Reuse Period: 14 days High-Level Disinfection Claim: 5 Minutes at room temperature (minimum of 20 o C) Sterilization Claim: 10 minutes at room temperature (minimum of 20ºC) Test Strip Verification of Minimum Recommended Concentration (MRC) Required: Yes Activation Required: Yes, Part A poured into bottle contents of Part B prior to use Corrosion Inhibitors: Yes Rapicide PA RTU is a reuseable use liquid chemical germicide solution with PAA in the concentration range of ppm. Rapicide PA RTU also contains corrosion inhibitors and water conditioning agents. INTENDED USE Rapicide PA RTU is intended to be used as a reusable liquid disinfectant solution for high-level disinfection and sterilization of endoscopes and related accessories in compatible AERs and for the manual disinfection of compatible medical devices. Rapicide PA RTU must be used at or above its MRC of 1000 ppm PAA with a contact time of at least 5 minutes at room temperature (minimum of 20 C) for a reuse period not to exceed 14 days. Rapicide PA Test Strips must be used to verify that the disinfectant concentration remains above the (MRC). Read and follow the directions for use and precautionary statements contained in the package insert before using. 4

5 SAFETY In handling Rapicide PA RTU, the following precautions should be followed: Rapicide PA RTU Parts A & B are corrosive and can cause eye damage and skin irritation. Always wear proper eye protection and protective gloves when handling Rapicide PA RTU. Avoid contact with eyes, skin and clothing. Wash thoroughly with soap and water after handling. Do not ingest or swallow. In case of contact with eyes or skin, flush with copious amounts of water for a minimum of 15 minutes. Seek immediate medical attention in case of eye contact. If swallowed, drink large amounts of water. Do not attempt to induce vomiting. Call a physician immediately. Avoid breathing fumes or vapors. Prepare and use Rapicide PA RTU only in well ventilated areas. Refer to product insert and manufacturer s instructions for reprocessing of medical devices in AER units. STORAGE Store Rapicide PA RTU at room temperatures (below 27 o C). NEUTRALIZATION AND DISPOSAL This use solution does not require neutralization or any additional specific safety measures prior to disposal. Dispose of any unused material including container in accordance with all applicable federal and local regulations. If allowed by federal or local regulatory authority, flush spilled solution to the drain using cold water. Run cold water for 15 minutes. Do not reuse the empty containers. 5

6 EFFICACY High-Level Disinfection Summary Rapicide PA RTU will high-level disinfect when used at or above its MRC of 1000 ppm PAA with a contact time of at least 5 minutes at room temperature (minimum of 20 o C) for a reuse period not to exceed 14 days. Sterilization Summary Rapicide PA RTU meets the requirements for a sterilization agent (> % reduction of bacterial endospores) when used at or above its MRC of 1000 ppm PAA with a contact time of at least 10 minutes at room temperature (minimum of 20ºC) for a reuse period not to exceed 14 days. Efficacy Testing Rapicide PA RTU was tested at 850 ppm PAA under worst case conditions according to AOAC methods and other applicable standards for microbiological testing for germicidal efficacy. Tests demonstrated sporicidal, bactericidal, fungicidal, tuberculocidal and virucidal efficacy. Table 1: Summary of Efficacy Testing - Rapicide PA RTU in 5 minutes at 20ºC TESTS ORGANISM RESULTS Sporicidal B. subtilis >5 log reduction* Tuberculocidal M. bovis M. terrac >4.8 log reduction Virucidal Adenovirus type 5 >5 log reduction Fungicidal Bactericidal C. albicans A. niger P. aeruginosa S. aureus E. feacalis E.nirae >4 log reduction >5 log reduction Bactericidal Methicillin resistant S. aureus (MRSA) Vancomycin resistant Enterococcus (VRE) >6 log reduction High-Level Disinfectant Simulated Use M. terrae >5 log reduction * >6 log reduction at 10 minutes 6

7 MATERIAL & ENDOSCOPE COMPATIBILITY Rapicide PA RTU is compatible with the following reusable devices and materials: endoscopes and related accessories; rubber, plastic, many types of metals (such as stainless steel, carbon steel, and aluminum). Rapicide PA RTU is recommended for high-level disinfection of medical devices made from materials shown in Table 2 below. These devices may be damaged if cleaned with highly alkaline detergent, poorly rinsed after disinfection, stored wet, or dried at temperatures exceeding 40 C (105 F). TABLE 2: List of Compatible Materials Metals Plastics and Elastomers 301 Stainless steel EPDM 304 Stainless steel Polyester 316 Stainless steel Polypropylene Ceramic Zr02-TXP Glass-filled polypropylene Tempered glass (ASTM C1048) PETP Inconel (nickel-chromium based alloy) PFA Hastelloy-C (nickel-chromiummolybdenum-tungsten PVC (flexible) alloy) PTFE Nylon Viton Silicone Santaprene Inglidur X Polysulfone PVDF Aflas (fluoroelastomer) The compatibility of Rapicide PA RTU has been examined both by running intensive endoscope exposure tests and by performing materials compatibility testing using a use solution with the same active ingredient and a closely related formulation. In addition, biocompatibility testing has been performed in order to demonstrate the proper rinsing of the chemical components from the endoscopes. 7

8 Endoscope compatibility testing was performed using representative Olympus and Fujinon endoscope models by subjecting them to 500 repeated cycles in two different AERs. Each cycle consisted of exposure to detergent, rinsing, a 6 minute disinfection cycle at the high end of the temperature range (32 C) to represent worst case conditions, followed by rinsing and alcohol. The endoscopes were inspected before and after the 500 HLD cycle run. The inspection was done by Surgical Repair inspected before and after 500 cycle exposure by an independent party, which involved functional evaluation of angulation, control, biopsy, insertion tub, light guide, suction, light guide connector, eyepiece, image, light illumination, air/water function, and leak testing. No change was observed in physical appearance or functionality, and the endoscopes passed all leak tests. Results of the compatibility evaluation indicate that endoscopes are compatible with repeated reprocessing and chemical exposure to Rapicide PA RTU. Material compatibility testing was performed that involved chemical exposure lifetime testing on representative materials commonly found in AERs, endoscopes and medical devices. The evaluation included exposure of the various metals, plastics and elastomers identified in Table 2 to Part A, Part B or the use solution for the estimated equivalent of 1.5 years of routine use. The exposure was followed by dimensional, weight, visual and infrared evaluation for compatibility. All components passed test requirements and the results demonstrate that Rapicide PA RTU is compatible with a wide range of materials commonly found in medical devices and AERs. In addition to endoscopes and material compatibility testing, studies were done to evaluate the toxicity of rubber material from the patient-contact distal end of representative endoscopes after exposure to 100 repeated reprocessing cycles in two different AERs. The exposed materials were evaluated for biologic sensitivity by a standard cytotoxicity test outlined in ISO Results of the cytotoxicity test showed that the exposed material was non-toxic and supports that devices repeatedly reprocessed properly using Rapicide PA RTU are safe and non-toxic for handling and use. Biocompatibility testing was also performed to examine the residuals on endoscopes after 1 and 100 repeated cycles of disinfectant exposure. These rinse residual studies showed that AER rinsing adequately rinses detergent and disinfectant residues from the surfaces of the endoscope, making it safe for both patients and hospital staff. The above testing indicates the Rapicide PA RTU is safe to use on endoscopes and the exposed device materials. No effect was observed on the endoscope components or functionality. 8

9 BIOCOMPATIBILITY Studies were conducted to determine the amount of chemical residuals remaining on endoscopes after reprocessing in an AER with Rapicide PA RTU and rinsing with water. In these studies representative Olympus, Fujinon and Pentax colonoscopies, which are considered to be the most difficult types of endoscopes to rinse due to large surface areas and long channels, were exposed to 100 repeated reprocessing cycles using detergent and a disinfectant solution with the same active ingredient and a closely related formulation as Rapicide PA RTU. Following exposure, the endoscopes were immediately and exhaustively extracted for 24 hours to remove all PAA and HP residues. This was followed by a 24 hour drying period and then an additional 4 hour residue extraction. The total extraction time was 28 hours, which is significantly longer than a typical endoscopy procedure of 15 minutes to 2 hours, and represents a worst case-scenario. Results of the extractions showed that the amounts of residuals, including hydrogen peroxide and proportional amount of PAA, remaining on endoscopes after rinsing were well below the acceptable exposure levels based on worst case human exposure limits determined from literature analysis. The results indicate adequate rinsing of Rapicide PA RTU residues and support that endoscopes and accessories are safe for handling and use after reprocessing. PACKAGING CONFIGURATION Rapicide PA RTU is available in the following packaging configuration. 4 bottles per case 2 bottles of Part A Approximately 1 liter bottles filled with 225 ml of solution 2 bottles of Part B 5 liter bottles filled with liters of solution 9

10 Manufactured in the USA by: Minntech Corporation th Avenue North Minneapolis MN USA Phone: Toll Free: Fax: Web: Minntech BV Sourethweg PC Heerlen The Netherlands Phone: Fax: info@minntechbv.com Minntech Asia / Pacific Pte Ltd 1A International Business Park #05-01 Singapore Phone: Fax: Minntech Beijing Representative Office Room 708, 7th Floor Kaiheng Center, No. 2 Chaoyangmennei Street Dongcheng District, Beijing China, Phone: Fax: